SEDIPANT 14CPR GASTR 20MG

SEDIPANT 20 MG COMPRESSE

active ingredients

Each gastrorexisting tablet contains 20 mg of pantoprazole as a sesquidated sodium pantoprazole. Excipient with known effects: - sorbitol (E420): 18 mg/compressed. For the full list of excipients, see the paragraph 6.1.

Excellent

Compressed core: Mannitol, Crospovidone (type B), Sodium carbonate, Sorbitol (E420), Calcium stearate. Coating Film: Ipromellose, Povidone, Titanium Dioxide (E 171), Iron Yellow Oxide (E 172), propylene glycol, Methacrylic-ethylcrilate copolymer (1:1) Dispersion 30%, Sodium laurilsulfate, Polysorbate 80, Macrogol 6000, Talco.

Therapeutic indications

Short-term treatment of reflux symptoms (e.g. pyrosis, gastric regurgitation) in adults.

Contraindications

Hypersensitivity to the active ingredient or any other excipient listed in paragraph 6.1. Co-administration of pantoprazole with HIV protease inhibitors for which absorption depends on intragastric acid pH such as atazanavir, nelfinavir, due to the significant reduction of their bioavailability (see paragraph 4.5).

Population

Population: The recommended dose is 20 mg of pantoprazole (one tablet) per day. To obtain an improvement of symptoms it may be necessary to take tablets for 2-3 consecutive days. Once the complete relief of symptoms occurred, treatment must be stopped. Treatment should not exceed 4 weeks without consulting doctor. In case you do not get a relief of symptoms within 2 weeks of continued treatment, the patient must be informed to consult the doctor. Special popularity: Dose adjustment is not required in elderly patients or patients with impaired kidney or liver function. Pediatric population: The use of Sedipanto is not recommended in children and adolescents under 18 years of age due to inadequate data on safety and effectiveness. Method of administration: Sedipanto 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with a little water before a meal.

Conservation

Store in the original packaging to protect the medicine from moisture. This medicine does not require any special storage temperature.

Warnings

Patients should be trained to consult the doctor if: - manifest non-intentional weight loss, anemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, as treatment with pantoprazole can relieve symptoms and delay the diagnosis of a severe condition. In these cases, evil nature must be excluded; - have had previous gastric ulcer or gastrointestinal surgery; - are in continuous symptomatic treatment for indigestion or pyrosis from at least 4 weeks or more; - have jaundice, liver impairment or liver disease; - have any other serious pathology that compromises the state of general health; - they are over 55 years old with new or recently changed symptoms. Patients with long-term recurring symptoms of indigestion or pyrosis must go to the doctor at regular intervals. In particular, patients over 55 who daily take indigestion or prescription-free pyrosis remedies should inform their physician or pharmacist. Patients should not take another protonic pump inhibitor or antagonist H₂. Patients who have to undergo an endoscopy or breathing test for urea should consult the doctor before taking this medicine. Patients should be informed that tablets are not intended to provide immediate relief. Patients may begin to experience an improvement of symptoms after about a day of treatment with pantoprazole, but it may be necessary to take it for 7 days to obtain full control of pyrosis. Patients should not take pantoprazole as prevention therapy. Gastrointestinal infections caused by bacteria: The reduced gastric acidity, due to any reason - including protonic pump inhibitors - increases the bacteria count normally present in the gastrointestinal tract. Treatment with medicines that reduce gastric acidity can lead to a modest increase in the risk of gastrointestinal infections caused by bacteria such as Salmonella, , Campylobacter and C. difficult. . Subacute skin lupus erythematous (LECS): Protonic pump inhibitors are associated with very rare cases of LECS. In case of injury, especially in the areas of the skin exposed to the sun, and if accompanied by artralgia, the patient must promptly request medical assistance and the doctor must consider the interruption of treatment with Sedipanto. The appearance of LECS after a previous treatment with a protonic pump inhibitor can increase the risk of LECS with other protonic pump inhibitors. Interference with laboratory exams: An increased level of Chromogranin A (CgA) can interfere with diagnostic tests for neuroendocrine tumors. To avoid such interference, the treatment with Sedipanto must be suspended for at least 5 days before the measurements of the CgA (see paragraph 5.1). If the levels of CgA and gastrin are not returned within the reference range after initial measurement, it is necessary to repeat the measurements 14 days after the interruption of treatment with protonic pump inhibitor. This medicine is intended only for short-term use (up to 4 weeks) (see paragraph 4.2). Patients should be advised about the additional risks of long-term use of the medicine and the need for prescription and regular monitoring. The following additional risks are considered relevant in the long term: Influence on the absorption of vitamin B12: Pantoprazol, like all injecting drugs, can reduce the absorption of vitamin B12 (cyanocobalamin) due to hypochloride or achloride. This possibility should be considered in long-term therapy in patients with reduced deposits or risk factors that reduce the absorption of vitamin B12 or in the presence of corresponding clinical symptoms. Fractures of the bone: Protonic pump inhibitors, especially when used for high doses and prolonged periods (> 1 year), may cause a slight increase in risk of hip fractures, pulse and spine fractures, especially in elderly patients or in the presence of other known risk factors. Observation studies suggest that protonic pump inhibitors could increase the overall risk of fracture from 10% to 40%. This increase may be partly due to other risk factors. Patients at risk of osteoporosis must receive treatment according to current clinical practice guidelines and should take appropriate amounts of vitamin D and calcium. Hypomaginemia: Severe hypomegnesisemia has been observed in patients treated for at least three months with pump inhibitors such as pantoprazole and in many cases for a year. Severe cases of hypomegnesisemia such as fatigue, tetania, delirium, convulsions, dizziness and ventricular arrhythmia may occur, but they may initially manifest insidious and be neglected. Hypomagnesiemia, in most patients, improves after taking magnesium and suspension of protonic pump inhibitor. Healthcare professionals should consider the possible measurement of magnesium levels at first and periodically in patients treated with pump inhibitors for a prolonged period or in digoxin therapy or medicines that may cause hypomagnesiemia (e.g. diuretics). Sedipanto contains sorbitol and sodium. This medicine contains 18 mg of sorbitol in each tablet. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “without sodium”.

Interactions

Sedipanto can reduce the absorption of active substances whose bioavailability depends on gastric pH (e.g. ketoconazole). HIV protease inhibitors : Contemporary pantoprazole administration is not recommended with HIV protease inhibitors for which absorption depends on intragastric acid pH as atazanavir, nelfinavir, due to the significant reduction of their bioavailability (see paragraph 4.3). Although interactions have not been observed in pharmacokinetics clinical trials during treatment with fenprocumone or warfarin, some isolated cases of variation of the International Normalized Ratio (INR) during concomitant treatment have been detected in the post-marketing period. Therefore, in patients treated with cumarinic anticoagulants (e.g. fenprocumone or warfarin), it is recommended to monitor protrombine/ INR when treatment with pantoprazole begins, when interrupted or when administered in a discontinuous manner. It has been shown that the concomitant use of high doses of metotrexate (e.g. 300 mg) and pump inhibitors can increase the serum levels of metotrexate in some patients. A temporary suspension of the pantoprazole can be considered. Pantoprazol is metabolized in the liver by the enzyme system of the P450 cytochrome. No significant interactions have been observed in specific tests with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glybenclamide, metoprolol, naprossene, nifedipine, phenytoin, pyroxicam, theophylline and an oral contraceptive containing levonorgestrel and etylestradiol. However, an interaction of pantoprazole with other metabolized substances from the same enzymatic system cannot be excluded. There were no interactions with antacids administered in conjunction.

Effects

Summary of security profile: One can expect that about 5% of patients manifest adverse reactions to the drug. The most commonly reported adverse reactions are diarrhea and headaches, both found in about 1% of patients. Tabular list of adverse reactions: The following adverse reactions were reported with pantoprazole. In the table below, adverse reactions are classified according to MedDRA frequency rating: very common (≥1/10); common (≥1/100, Table 1. Adverse reactions with pantoprazole in clinical studies and post-marketing experience

Frequency Classification for systems and organs	Town	Not common	Rare	Very rare	Notable
Emolinfopoietic system pathologies			Agranulocytes	Trombocytopenia; Leucopenia Pancitopenia
Immune system pathologies			Hypersensitivity (including anaphylactic reactions and anaphylactic shock)
Disorders of metabolism and nutrition			Hyperlipidemias and increased lipids (triglycerides, cholesterol); weight variations		Hyponatremia Hypomagnesemia Hypocalcemia (1)
Psychiatric disorders		Sleep disturbances	Depression (and every worsening)	Disorientation (and any worsening)	Hallucinations; confusion (especially in patients prepared, as well as aggravation of these symptoms in case of pre-existence)
Diseases of the nervous system		Cefalea Capogiri	Disorders of taste		Opinion
Pathologies of the eye			Disorders of blurred vision/vision
Gastrointestinal diseases	Fungus gland polyps (drinks)	Diarrhea; Nausea / vomiting; Abdominal distension and swelling; Stipsi; Dry mouth; Pain and abdominal disorders			Microscopy Colite
Hepatobiliary diseases		Increased liver enzymes (transaminasis, γ-GT)	Increase in bilirubin		Hepatocellular lesion; jaundice; hepatocellular insufficiency
Pathologies of skin and subcutaneous tissue		skin irritation/exantema/eruption; itching	Orthics; angioedema		Stevens-Johnson syndrome; lyell syndrome; multiform erythema; photosensitivity; Herimatous subacute skin lupus (see paragraph 4.4)
Diseases of musculoskeletal system and connective tissue		Pulse fracture, hip and spine fracture	Artralgia; mialgia
Kidney and urinary pathologies					Interstitial nephritis
Systemic pathologies and conditions for administration		Astenia, fatigue and malaise	High body temperature; peripheral edema
Pathologies of the reproductive apparatus and of the breast			Gynecomastia

⁽¹⁾ Hypocalcemia in association with hypomagnesemia. Reporting of suspected adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Doses up to 240 mg administered intravenously in 2 minutes were well tolerated. Since pantoprazol is widely linked to proteins, it is not readily dialysis. In case of overdose with clinical signs of intoxication, specific therapeutic recommendations cannot be made, except for symptomatic treatment and support.

Pregnancy

: There is no adequate data regarding the use of pantoprazole in pregnant women. Animal studies have shown reproductive toxicity. Preclinical studies did not detect evidence of compromised fertility or teratogenic effects (see paragraph 5.3). The potential risk for human beings is not known. Pantoprazole should not be used during pregnancy.

Food

: Pantoprazole/metabolites have been identified in breast milk. The effects of pantoprazole on infants/infaents are unknown. Seat should not be used during breastfeeding.

Fertility

: In animal studies there was no evidence of fertility impairment following pantoprazole administration (see paragraph 5.3).

Source: Farmadati